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      • Development and evaluation of orodispersible tablets using a natural polysaccharide isolated from Cassia tora seeds

        Harshal Pawar,Chhaya Varkhade,Pravin Jadhav,Kavita Mehra 한국한의학연구원 2014 Integrative Medicine Research Vol.3 No.2

        Background: Orodispersible tablets or fast dissolving tablets dissolve or disintegrate imme-diately on the patients’ tongue or buccal mucosa. This drug delivery system is suitable fordrugs undergoing high first pass metabolism. It improves bioavailability, reduces dosingfrequency, and thereby minimizes the side effects and also makes the dosage form morecost-effective. In this study, polysaccharide isolated from the seeds of Cassia tora was inves-tigated as a superdisintegrant in the orodispersible tablets. The model drug chosen wasvalsartan, an antihypertensive drug.Methods: Valsartan tablets were prepared separately using different concentrations (1%, 2.5%,5%, and 7.5% w/w) of isolated C. tora seed polysaccharide (natural) and sodium starch glyco-late (synthetic) as superdisintegrant by the direct compression method. Evaluation of tabletswas done for various pre- and postcompression parameters. The stability studies were per-formed on optimized formulation F4. The disintegration time and in vitro drug release of theformulation F4 were compared with marketed formulations (conventional tablets).Results: The drug excipient interactions were characterized by Fourier transform infraredstudies. The formulation F4 containing 7.5% polysaccharide showed good wetting timeand disintegration time as compared to a formulation prepared using a synthetic super-disintegrant at the same concentration level. Hence, batch F4 was considered optimizedformulation.Conclusion: The present work revealed that C. tora seed polysaccharide has a good potentialas a disintegrant in the formulation of orodispersible tablets. Because C. tora polysaccharideis inexpensive as compared to synthetic superdisintegrants, nontoxic, compatible, and easyto manufacture, it can be used in place of currently marketed superdisintegrants.

      • SCOPUSKCI등재

        The Efficacy and Safety of Tetrachlorodecaoxide in Comparison with Super-oxidised Solution in Wound Healing

        Parikh, Romil,Bakhshi, Girish,Naik, Madhushree,Gaikwad, Bhargav,Jadhav, Kavita,Tayade, Mukund Korean Society of Plastic and Reconstructive Surge 2016 Archives of Plastic Surgery Vol.43 No.5

        Background Some of the relatively newer, more efficacious, and potent topical wound dressing solutions include tetrachlorodecaoxide and super-oxidised solution. This study compares the efficacy and safety of these two drugs. Methods This is a block-randomised, double blind, parallel-arm, post-marketing study. One hundred fifty patients with ulcers (75 blocks uniform for sex, ulcer aetiology, diabetes mellitus, and wound area score) were randomised into the two treatment arms. Patients were observed for eight weeks with weekly assessments. One hundred and twenty patients completed the study. Wound healing was objectively assessed by measurement of wound area, scoring of wound exudation and tissue type, and using the pressure ulcer scale of healing Tool (validated for multiple wound aetiologies). Subjective improvement in pain was noted using a visual analogue scale. Both groups were compared using Mann-Whitney U test on all indicators. Results Difference in change in wound tissue type in the two groups was significant (${\alpha}$=0.05) by intention-to-treat (ITT) and per-protocol (PP) analysis at the end of week two (ITT and PP, P<0.001) and week four (ITT, P=0.010; PP, P=0.009). P-values for other comparisons were not significant (P>0.05). No study-related adverse events were observed. Conclusions Both drugs are efficacious. Tetrachlorodecaoxide yields healthy granulation tissue earlier. Both drugs appear to be safe for application.

      • KCI등재

        The Efficacy and Safety of Tetrachlorodecaoxide in Comparison with Super-oxidised Solution in Wound Healing

        Romil Parikh,Girish Bakhshi,Madhushree Naik,Bhargav Gaikwad,Kavita Jadhav,Mukund Tayade 대한성형외과학회 2016 Archives of Plastic Surgery Vol.43 No.5

        Background Some of the relatively newer, more efficacious, and potent topical wound dressing solutions include tetrachlorodecaoxide and super-oxidised solution. This study compares the efficacy and safety of these two drugs. Methods This is a block-randomised, double blind, parallel-arm, post-marketing study. One hundred fifty patients with ulcers (75 blocks uniform for sex, ulcer aetiology, diabetes mellitus, and wound area score) were randomised into the two treatment arms. Patients were observed for eight weeks with weekly assessments. One hundred and twenty patients completed the study. Wound healing was objectively assessed by measurement of wound area, scoring of wound exudation and tissue type, and using the pressure ulcer scale of healing Tool (validated for multiple wound aetiologies). Subjective improvement in pain was noted using a visual analogue scale. Both groups were compared using Mann–Whitney U test on all indicators. Results Difference in change in wound tissue type in the two groups was significant (α= 0.05) by intention-to-treat (ITT) and per-protocol (PP) analysis at the end of week two (ITT and PP, P<0.001) and week four (ITT, P=0.010; PP, P=0.009). P-values for other comparisons were not significant (P>0.05). No study-related adverse events were observed. Conclusions Both drugs are efficacious. Tetrachlorodecaoxide yields healthy granulation tissue earlier. Both drugs appear to be safe for application.

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